Leucidal SF Complete

SECTION 2: Hazards identification

1999/45/EC Classification GHS / CLP Basis for Classification Based on present data no classification and labeling is required according to GHS, taking into account the national implementation (United Nations version 2011) USA

2.2 Label elements

Pictograph: No hazard symbol expected Hazard statements/Signal Word: Not applicable

Precautionary statements

P233: Keep container tightly closed P281: Use personal protective equipment as required P402: Store in a dry place P404: Store in a closed container P410: Protect from sunlight P411: Store at temperatures not exceeding 25°C

Other hazards which do not result in classification

No particular fire or explosion hazard. By mechanical effect: No particular hazards. By hydroscopic effect: No particular hazards.

Health hazards

Rating 0; Normal Material Flammability: Rating 0, Will Not Burn Reactivity: Rating 0, Stable

2.3 Other hazards

None

PBT Substances

Not applicable

vPvB Substances

Not applicable

2.1 Classification of the substance or mixture

GHS / CLP Basis for Classification: Based on present data no classification and labeling is required according to GHS, taking into account the national implementation (United Nations version 2011) USA OSHA Regulatory Status: This material is non-hazardous as defined by the American OSHA Hazard Communication Standard (29 CFR 1910.1200). Europe Basis for Classification: -According to present data no classification and labeling is required according to Directives 67/548/EEC or 1999/45/EC. -This product is not classified as hazardous to health or environment according to the CLP regulation. Labeling Elements: Pictograph: No hazard symbol expected Hazard statements/Signal Word: Not applicable Precautionary statements: P233: Keep container tightly closed P281: Use personal protective equipment as required P402: Store in a dry place P404: Store in a closed container P410: Protect from sunlight P411: Store at temperatures not exceeding 25°C Other hazards which do not result in classification: No particular fire or explosion hazard. By mechanical effect: No particular hazards. By hydroscopic effect: No particular hazards. US NFPA 704 (National Fire Protection Association) Hazard Rating System: Health hazard: Rating 0; Normal Material Flammability: Rating 0, Will Not Burn Reactivity: Rating 0, Stable Other Hazard Information: None Results of PBT and vPvB assessment: -PBT: Not applicable -vPvB: Not applicable SECTION 3. COMPOSITION / INFORMATION ON INGREDIENTS Common Chemical Name: Lactobacillus Ferment & Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract Generic name: Chemical Family: Blend Description: Mixture: consisting of the following components. This section describes all components of the mixture Substance CAS Numbers EC Numbers Percentage Lactobacillus Ferment 1686112-36-6 N/A 75.00% Lactobacillus 68333-16-4 N/A 20.00% Cocos Nucifera (Coconut) Fruit Extract 8001-31-8 232-282-8 5.00% Formula: Not applicable SECTION 4. FIRST-AID MEASURES General: In all cases of doubt, or when symptoms persist, seek medical attention. Inhalation: Move to fresh air from exposure area. Get medical attention for any breathing difficulty. Skin contact: Rinse with soap and water. Get medical advice if irritation develops. Eye contact: Immediately rinse with water for at least 15 minutes, while keeping the eyes wide open. Consult with a physician. Ingestion: Consult with a physician. Protection of first-aiders: No special protection required. SECTION 5. FIRE-FIGHTING MEASURES Fire and explosion hazards: Not considered to be a fire and explosion hazard Extinguishing media: Suitable: Water, dry chemicals, foam & carbon dioxide. Not suitable: None known Fire fighting: Move container from fire area if it can be done without risk. Avoid inhalation of material or combustion by-products. Stay upwind and keep out of low area Protection for fire-fighters: Boots, gloves, goggles. SECTION 6. ACCIDENTAL RELEASE MEASURES Personal precautions: Avoid contact with eyes. Personal Protective Equipment: -Protective goggles Environmental precautions: Prevent entry into sewers and waterways. Do not allow material to contaminate ground water system Methods for cleaning up: Recovery: Pick up free liquid for recycling or disposal. Residual liquid can be absorbed on an inert material. Cleaning/Decontamination: Wash non-recoverable remainder with water. Disposal: For disposal of residues refer to sections 8 & 13. SECTION 7. HANDLING AND STORAGE Handling Technical measures: Labeling: Keep out of the reach of children. Measures: For industrial use, only as directed. Safe handling advice: Wash hands after use. Avoid storage near feed or food stuff. Storage Technical measures: Keep container closed. Recommended Storage Conditions: Store in a cool, dry place. This product should be stored at room temperature (23 - 25°C). It should not be exposed to excessive heat or cold. Do not freeze. Incompatible products: Avoid contact with strong oxidizers. Refer to the detailed list of incompatible materials (Section 10 Stability/Reactivity) Packaging: Product may be packaged in normal commercial packaging. Packaging materials: Recommended - Polypropylene & High Density Polyethylene SECTION 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Precautionary statements: Ensure adequate ventilation Control parameters Occupational exposure Limits: France: Not Determined ACGIH: Not Determined Korea: Not Determined UK: Not Determined Surveillance procedures: Not Determined Engineering measures: Not Determined Personal Protective Equipment: Respiratory protection: Local exhaust Hand protection: Protective gloves made of rubber or neoprene. Eye protection: Safety glasses. Collective emergency equipment: Eye fountain. Skin and Body Protection: Suitable protective clothing Hygiene measures: Handle in accordance with good industrial hygiene and safety practice. Measures related to the Environment: No particular measures. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance: Clear to hazy liquid Color: Colorless to light yellow Odor: Characteristic pH: 7.0 – 10.0 Specific Gravity: 0.990 – 1.110 NVM (1g-105°C-1hr): 8.0 – 12.0% Heavy Metals: < 20 ppm Arsenic: < 2 ppm Minimum Inhibitory Concentration Organism (ATCC#): E. coli (#8739): 0.50 – 4.00% S. aureus (#6538): 0.25 – 1.00% P. aeruginosa (#9027): 0.25 – 1.00% C. albicans (#10231): 0.25 – 1.00% A. brasiliensis (#16404): 0.25 – 1.00% Vapor density: Not applicable Boiling Point: 100°C Freezing Point: 0°C Melting point: Not applicable Flash point: > 200°F Oxidizing properties: Non oxidizing material according to EC criteria. Solubility: In water: Soluble In organic solvents: Not determined Log P: Not determined SECTION 10. STABILITY AND REACTIVITY Stability: Stable under ordinary conditions of use and storage up to one year then re-test to full product specifications to extend shelf life Hazardous reactions: None known Conditions to avoid: No dangerous reactions known under use of normal conditions. Avoid extreme heat. Materials to avoid: No dangerous reaction known with common products. Hazardous decomposition products: None known SECTION 11. TOXICOLOGICAL INFORMATION Ingestion: Not Determined Dermal: Non-Irritant (Dermal Irritection Model) Ocular: Non-Irritant (Ocular Irritection Model) Inhalation: Not Determined Acute toxicity data: EC50 (Acute Daphnia): 143.9 mg/L - Not harmful to aquatic organisms Sensitization: Non-Primary Sensitizer; Will not cause allergic contact dermatitis (In Chemico Skin Sensitization Direct Peptide Reactivity Assay & In Vitro Skin Sensitization ARE-Nrf2 Luciferase Test Method) Repeated dose toxicity: No known effects Subacute to chronic toxicity: Not Determined Mutagenicity: Non-Mutagenic (OECD471/ISO10993.Part 3 – Genotoxicity: Bacterial Reverse Mutation Test) Additional Toxicological Information: This product is not subject to classification according to the calculation method of the General EU Classification Guidelines for Preparations as issued in the latest version. Specific effects: Carcinogenicity: No known effects Mutagenicity: No known effects Reproductive toxicity: No known effects Neuro-toxicity: No known effects For more information: Does not present any particular risk on handling under normal conditions of good occupational hygiene practice. This product has not been tested for the following: -Primary cutaneous and corrosive irritation -Acute oral toxicity SECTION 12. ECOLOGICAL INFORMATION Ecotoxicity Effects on the aquatic environment: Not Determined Biodegradability: Persistence: Readily Biodegradable (91.5% biodegradation after 28 days of testing) Bioaccumulation: Octanol / water partition coefficient: Not Determined Mobility: Precipitation: Expected behavior of the product: Ultimate destination of the product: Soil & sediment. Other Adverse Effects: None known SECTION 13. DISPOSAL CONSIDERATIONS Residues from product Prohibition: Do not allow the product to be released into the Environment. Destruction/Disposal: Dispose of in accordance with relevant local regulations Contaminated packaging Decontamination/cleaning: Cleaning is not required prior to disposal. Destruction/Disposal: Note: Take all necessary precautions when disposing of this product according to local regulations. SECTION 14. TRANSPORT INFORMATION UN Number: None UN Shipping Name: None Transport Hazard Class: Not classified as dangerous for transport Land (rail/road): Material is not restrictive for land transport and is not regulated by ADR/RID Sea: Material is not restrictive for sea transport and is not regulated by IMO/IMDG Air: Material is not restrictive for land transport and is not regulated by ICA/IATA Marine Pollutant: No Transport/Additional Information: Not regulated for US DOT Transport in non-bulk containers This material is not dangerous or hazardous Special Precautions for User: None known The above regulatory prescriptions are those valid on the date of publication of this sheet. However, given the possible evolution of transport regulations for hazardous materials and in the event of the MSDS in your possession dating back more than 12 months, it is advisable to check their validity with your sales office. SECTION 15. REGULATORY INFORMATION Labeling: EC regulations: This product does not need to be labeled in accordance with EC Directives or respective national laws Further regulations United Kingdom: Handle in accordance with relevant British regulation: control of substance Hazardous to Health Regulations Environmental Hygiene Guidance: EH40 Workplace Exposure Limits (revised annually) Korea regulations: Industrial safety and hygiene regulation: No Hazardous material control regulation: No Fire prevention regulation: No Other regulations: EINECS inventory status: Lactobacillus Ferment: N/A Lactobacillus: N/A Cocos Nucifera Fruit Extract: 232-282-8 TSCA inventory status: Exempt AICS inventory status: Not Listed: 1686112-36-6 Listed: 68333-16-4 & 8001-31-8 Canadian (CEPA DSL) inventory status: Not Listed: Lactobacillus Ferment (1686112-36-6) Listed as Lactobacillus acidophilus (Revised ICL) & Coconut Oil (DSL) Japan (MITI list): Lactobacillus Ferment & Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract Korea: Lactobacillus Ferment & Lactobacillus** & Cocos Nucifera (Coconut) Fruit Extract** China inventory status: Lactobacillus Ferment & Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract Philippines inventory status: Not Listed: Lactobacillus Ferment (1686112-36-6) & Lactobacillus (68333-16-4) Listed as Coconut Oil **Not listed in 2004 CTFA Dictionary – Registered with Personal Care Products Council Note: The regulatory information given above only indicates the principal regulations specifically applicable to the products described in this sheet. The user’s attention is drawn to the possible existence of additional provision which complete these regulations. Please refer to all applicable international, national and local regulations and provisions SECTION 16. OTHER INFORMATION Prohibited uses: For specific uses, food industry, ask the manufacturer for more information. Last Revision Date: 02/01/2016 Preparation Date: 07/14/2016 MSDS summary of changes - Added Irritation Data – Section 11 (Toxicological Information) - Added Mutagenicity Data – Section 11 (Toxicological Information) - Added Acute Toxicity, Sensitization & Mutagenicity Data – Section 11 (Toxicological Information) & Biodegradability Data – Section 12 (Ecological Information) - Added Minimum Inhibitory Concentration – Section 9 (Physical & Chemical Properties) - Updated Minimum Inhibitory Concentration – Section 9 (Physical & Chemical Properties) - Updated CAS/EINEC#’s – Section 3 (Composition / Information on Ingredients) & Section 15 (Regulatory Information) The information given is based on our knowledge of this product, at the time of publication in good faith. The attention of the user is drawn to the possible risks incurred by using the product for any other purpose other than which it was intended. This is not in any way excuse the user from knowing and applying all the regulations governing their activity. It is sole responsibility of the user to take all precautions required in handling the product. The purpose of mandatory regulation mentioned is to help the user to fulfill his obligations regarding the use of products. This information is not exhaustive, this is not exonerate the user from ensuring that legal obligations other than those mentioned, relating to the use and storage. Arrival of Materials Fail Tests for Acceptance Pass Fermentation of Lactobacillus in a Defined Media under Controlled Condition of pH, Cocos Nucifera Fruit is Temperature and Time Macerated and Fermented with Lactobacillus at Specific pH and Temperature for Specific duration Add Lysozyme to Facilitate Controlled Cell Lysis Filtration Blending Make batch adjustments if needed Fail Sample for QC Pass Pack Material Sample for Micro Passes Micro Ship to Customer Certificate of Compliance Code: M15025 INCI Name: Lactobacillus Ferment & Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract INCI Status: Conforms CAS #: 1686112-36-6 & 68333-16-4 & 8001-31-8 EINECS #: N/A & N/A & 232-282-8 The following information on regulatory clearances is believed to be accurate and is given in good faith as a guide to a global use of our ingredients in cosmetic applications. No representation or warranty as to its competences or accuracy is made. Information is offered for use in general cosmetic applications and may vary in particular applications. Users are responsible for determining the suitability of these products for their own particular use. All regulatory decisions should be made on the advice of your regulatory group or legal counsel. Country / Regulatory Body Status of Product EU (REACH) Compliant USA (TSCA) Exempt Australia (AICS) Contact Us Japan (METI) Compliant Canada (DSL) Contact Us China (IECSC) Compliant Brazil (ANVISA) Compliant Korea (KECI) Compliant Philippines (PICCS) Contact Us Code: M15025 Attention must be paid to the use of Leucidal® SF Complete in the equivalent of OTC formulations (eg. quasi-drugs in Japan, or therapeutic goods in Australia). Some countries maintain restricted inventories of raw materials that can be used in those applications so more detailed guidance may be required. Leucidal® SF Complete and any components or impurities are in compliance with the rules governing cosmetic products in the European Union (Directive 76/768/ECC & Regulation No. 1223/2009). The recommended use levels for Leucidal® SF Complete is 2.00 – 4.00%. Leucidal® SF Complete is in compliance with the standardized set of rules developed and approved by the NPA (Natural Products Association). Leucidal® SF Complete is considered a non-hazardous material. All significant toxicological routes of absorption have been considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL). Due to the restriction placed on animal testing of cosmetic raw materials, and Active Micro Technologies, LLC’s internal non-animal testing policy, this product was not tested for NOAEL. Leucidal® SF Complete was tested using in vitro dermal and ocular irritation models. This product was found to be non-irritating in both models. To our knowledge the above material is free of CMR (*) substances, as defined according to Regulation (EC) No 1272/2008 and Cosmetic Regulation (EC) No 1223/2009 as amended. (*) Carcinogenic, Mutagenic, toxic for Reproduction Active Micro Technologies, LLC certifies that to the best of our knowledge our product does not contain any material listed on California Proposition 65. Active Micro Technologies, LLC certifies that Leucidal® SF does not contain any materials prohibited by Halal laws. Leucidal® SF Complete is REACH Compliant and free of the following: • Formaldehyde or formaldehyde donors • Parabens • Glycol ethers • Paraffin/petroleum products • Gluten • Phthalates • Lactose • Polyethylene glycol (PEG) • Nanoparticles • Residual solvents • Nitrosamines • Sulfates • Palm oil/palm kernel oil (or derivatives) • Volatile organic compounds Version#4/08-19-16/Form#62 F363(COS)v05en VERIFICATION OF THE RAW MATERIALS CONFORMITY TO THE ECOCERT AND COSMOS COSMETIC STANDARDS THIS DOCUMENT IS NOT AN ORGANIC CERTIFICATE Company: ACTIVE MICRO TECHNOLOGIES LLC Attestation n° : 5548 Page 1 on 1 The conformity (conf.) is established according to the requirements related to the raw materials contained in the applicable standard(s). The present document is only valid for ECOCERT until official COSMOS publication of the raw materials on the website: http://www.cosmos-standard-rm.org/ *reference related to the appendices II and/or V of the Cosmos standard. Leucidal Liquid Complete (M15024) Function: Moisturizing, Skin conditioning, Antimicrobial INCI: Leuconostoc/Radish Root Ferment Filtrate (and) Lactobacillus (and) Cocos Nucifera (Coconut) Fruit Extract Conf. ECOCERT: YES 100 % of natural origin ( 0 % of physically processed vegetal ingredients) 0 % synthetic Conf. COSMOS: YES PPAI : 0 % CPAI : 64% Petrochemical moiety : 0 % Non natural ingredient : 0 % Comments: Leucidal SF Complete (M15025) Function: Moisturizing, Skin conditioning, Antimicrobial INCI: Lactobacillus Ferment (and) Lactobacillus (and) Cocos Nucifera (Coconut) Fruit Extract Conf. ECOCERT: YES 100 % of natural origin ( 0 % of physically processed vegetal ingredients) 0 % synthetic Conf. COSMOS: YES PPAI : 0 % CPAI : 32,5% Petrochemical moiety : 0 % Non natural ingredient : 0 % Comments: Drawn up in l'Isle Jourdain, valid from 18/02/2016 Matthieu Bouffartigue until 31/12/2016 Raw Materials Service Manager WARNING: The present document belongs to ECOCERT Greenlife SAS. It must be erased on ECOCERT request. The approval of the raw material(s) listed above is PERSONAL to the beneficiary named herein, and the BUYERS of the raw material(s) ARE IN NO EVENT AUTHORIZED TO MAKE REFERENCE TO THE APPROVAL BY ECOCERT GREENLIFE OR TO USE AN ECOCERT LOGO, whether in its communication or on the packaging or labeling of the raw material(s) or of a finished cosmetic product. ECOCERT GREENLIFE S.A.S. - Capital 50 000 € – Lieudit Lamothe Ouest – 32600 L’Isle Jourdain - France Tél. + 33 (0)5 62 07 51 09 - Fax : +33 (0)5 62 07 74 96 – www.ecocert.com TVA Intracommunautaire n° FR 55 509 534 095 CREDIT MUTUEL 2200 20246201 29 - SIREN 509 534 095 RCS AUCH - APE 7120B